The development of effective devices that can transport and deliver a drug precisely and safely to its target is a major challenge in the drug delivery field. New delivery technologies are developed each year that target nearly every part of the human body as potential routes for administering established and new drugs. These novel drug delivery technologies include nasal systems, transdermal patches, implants, and micro- and nano-devices.
The main goal of drug delivery systems is to deliver the drug to the target location at the required level in a safe and reproducible manner. There are many routes for administering drugs; the oral route is the most common and preferred method for drug delivery as it is non-invasive. However, the drug is gradually lost through the metabolism as it travels through the liver, stomach, and intestine. Other commonly used routes are the nasal drug delivery and injection. (Illum L. Nasal drug delivery: new developments and strategies. Drug Discovery Today. 2002; 7: 1184-1189; Merkus FWHM, et al. Cyclodextrins in nasal drug delivery. Adv Drug Deliv Rev. 1999; 36: 41-57). The nasal delivery shows poor absorption of polar compounds and the injection approach is normally associated with pain so patients tend to avoid this method. (Illum L. Nasal drug delivery: new developments and strategies. Drug Discovery Today. 2002; 7: 1184-1189). Transdermal techniques have also been proposed to deliver the drug to the bloodstream through the skin. (Langer R. Where a pill won't reach. Sci Am. 2003; 288: 50-57; McAllister D V, Allen M G, and Prausnitz M R. Microfabricated microneedles for gene and drug delivery. Annu Rev Biomed Eng. 2000; 2: 289-313; Henry S, McAllister D V, Allen M G, and Prausnitz M R. Microfabricated microneedles: a novel approach to transdermal drug delivery. J Pharm Sci. 1998; 87: 922-925).
According to the National Cancer Institute, ovarian cancer is accountable for the highest mortality rates of all gynecologic cancers. It is estimated that more than 21,000 new cases will be diagnosed and approximately 15,000 deaths will occur from ovarian cancer in 2009 in the U.S. Once ovarian cancer is detected, there are several treatments available that include surgery, radiation, and systemic chemotherapies. The major drawback of most current treatments with the exception of surgery is that they tend to kill the normal cells and tissues along with the cancerous cells throughout the body. Currently, surgery to remove the ovaries is considered the most effective treatment. However, the removal of ovaries can lead to side effects as ovaries are responsible for producing the female hormones that are important to a woman's health.
Most anticancer drugs are given via oral or injection methods. These drug delivery approaches can kill normal cells and tissues or lead to the gastrointestinal absorption of the drug before reaching the ovaries and areas within the pelvic cavity thus diminishing the effectiveness of the drugs.
Studies are exploring the potential of using the vagina as an alternative route for drug delivery. There are several factors that need to be taken into consideration when using the vagina as a route for drug delivery such as the drug formulation, age, hormone status, pH, and vaginal fluids (Hussain, A. and F. Ahsan, The vagina as a route for systemic drug delivery. J Control Release, 2005. 103(2): p. 301-13; Alexander, N. J., et al., Why consider vaginal drug administration? Feral Steril, 2004. 82(1): p. 1-12). When these factors are taken into consideration, advantages of using the vaginal route include: localized drug delivery, ease of administration, and by-passing the first metabolic reactions (Justin-Temu, M. D., Festo; Kinget, Renaat; Van Den Mooter, Guy, Intravaginal Gels as Drug Delivery Systems. Women's Health, 2004. 13).
The main goal of the medical device of the present invention is to transport and deliver a drug directly to the ovaries at the required level in a safe and non-invasive manner. The delivery of the drug directly to the ovaries enables a high concentration of the drug to reach the target location thus increasing the effectiveness of the drug on the patient. The direct delivery of drug via this device can also minimize dosage frequency and drug side effects. The device can be used for targeted drug delivery for the treatment of ovarian cancer, as well as for targeted sperm delivery and treating bacterial infection and inflammation.